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UDI: Medical Device Profits at Risk – Unnecessarily
Traceability for containing issues and UDI compliance is an ongoing cycle. How many companies’ profit margins will plummet because of the FDA’s Unique Device Identifier (UDI) requirements? Quite a few,...
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Streamline compliance using MES for quality
Fast trains streamline travel and MES can streamline Quality by integrating it with operations. How much is your cost of compliance? Manufacturers of regulated products such as medical devices often...
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Benefits beyond the “have to”
Complying with a regulation or “have to” can lead to benefits that more than offset the burden of change. Nearly everyone has “have to” or “should in their vocabulary, and feels there are things that...
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Realities for UDI and Beyond
UDI Lessons Learned Webcast with Jay Crowley and Cathi Crist was a revealing look at what companies need to do The #1 concern that keeps medical device professionals awake at night is compliance with...
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Re-framing in Medical Devices
Regulations – such a burden on the medical device industry. Or are they? I am advocating that companies Can you see the opportunity or just the burden of regulation? This is just one example from eDHR....
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